Health TrialsbyHealthPanel

Effects of Telitacicept vs Cyclophosphamide on Lupus Related Interstitial Lung Disease

ConditionsLupus or SLEInterstitial Lung DiseaseSystemic Lupus Erythematosus
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorTongji Hospital

About this trial

Recent data indicate that Telitacicept is beneficial for lupus nephritis. Our goal is to determine whether Telitacicept is an effective and safe treatment, compared to standard-of-care Cyclophosphamide, for subclinical and clinical ILD in patients with early lupus.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Meet the 2019 EULAR/ACR classification criteria for systemic lupus erythematosus;

Male or non-pregnant female aged ≥ 18 years;

Diagnosis by high-resolution lung CT (HRCT) is clearly consistent with interstitial lung disease (ILD);

FEV1/FVC%≥60% and diffusion function DLCO (measured value/estimated value) ≥40%;

Disqualifiers

Alanine aminotransferase and/or aspartate aminotransferase (ALT/AST) > 5 times the upper limit of normal;

severe chronic kidney disease (stage IV) or need for dialysis (estimated glomerular filtration rate (eGFR) < 30ml/min/1.73m2);

Hemoglobin < 80 g/L;

WBC < 2.0×10^9;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Methylprednisolone (Corticosteroid)

    Drug

    In addition to conventional treatment (methyl-40mg or less /d), the treatment group also received hydroxychloroquine (100mg-200mg each time twice a day), and thalidomide (50mg-100mg each time once a day) could be added as appropriate.

  • Immunosuppressant other than CYC

    Drug

    The control group only received conventional treatment (methyl 40 mg/d or less), and other traditional immunosuppressants (including but not limited to cyclophosphamide, tacrolimus, sirolimus, cyclosporine, leflunomide, azathioprine, motecophenol ester, hydroxychloroquine, tripterine, methotrexate and sulazazopyridine, etc.). No more than 3 types of immunosuppressant should be added during the whole treatment period, and the dose should not exceed 30% from the baseline period)

  • Telitacicept Freeze-dried powder Injection 80mg

    Drug

    Telitacicept is a TACI-Fc fusion protein, a type of drug used to treat autoimmune diseases. It works by targeting two key proteins, BLyS and APRIL, which are involved in the development and function of B cells, a type of white blood cell. By blocking these proteins, telitacicept can help to reduce B cell activity and suppress the immune system's overactivity in autoimmune diseases. Subcutaneous injection dose ranges from 80mg once a week to 160mg once a week.

  • Cyclophosphamide (CYC)

    Drug

    Cyclophosphamide iv injection is used for severe complications of systemic lupus erythematosus 400mg twice a week

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: glucocorticoids and/or immunosuppressants other than CYC+ treatment with the Telitacicept groupExperimental treatment 3 interventions
Group B: glucocorticoids plus CYC and/or other immunosuppressantsActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Correlation between change from baseline at week 52 in forced vital capacity (FVC) [percentage (%) predicted]

Pulmonary function measurement (FEV1/FVC% % post-treatment difference during baseline)

Time frame
At baseline and at week 24, 52

Secondary outcomes

1

Correlation between change from baseline at week 52 in diffusing capacity for carbon monoxide (DLco) [percentage (%) predicted]

Diffuse function DLco measurement (% post-treatment difference at baseline)

Time frame
At baseline and at week 24, 52
2

Anti-double-stranded DNA antibody conversion ratio

Anti-double-stranded DNA antibody conversion ratio

Time frame
At baseline and at week 12, 24, and 52
3

Complement C3 and C4 levels return to normal ratios

Complement C3 and C4 levels return to normal ratios

Time frame
At baseline and at week 12, 24, and 52
4

Six minutes walking distance

The 6-minute walk test (6MWT) is a simple, submaximal exercise test commonly used to assess functional capacity in individuals with interstitial lung disease (ILD). It measures the distance a person can walk in six minutes, and this distance (6MWD) can be correlated with disease severity and prognosis.

Time frame
At baseline and at week 12, 24, and 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tongji Hospital

Lead sponsor

Wuhan Central Hospital

Collaborator

Wuhan Hospital of Traditional Chinese Medicine

Collaborator

Rongchang Biopharmaceutical

Collaborator

Johns Hopkins Bloomberg School of Public Health

Collaborator

Source ClinicalTrials.gov
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